Active Ingredient(S)
Undecylenic Acid 25%
Terbinafine 1%
Kimtara Nail Fungus Treatment Liquid
FDA Label NDC 84558-023
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Yusong Fine Chemicls Co., Ltd for the product Kimtara Nail Fungus Treatment (NDC 84558-023). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Use
Treats athlete's foot, ringworm, and jock itch.
Helps improve the appearance of fungus-affected nails.
Warnings
For external use only.
Do Not Use
Do not use on children under 2 years unless directed by a doctor.
Avoid contact with eyes. Rinse with water if contact occurs.
Otc - When Using
avoid contact with eyes
do not apply to irritated or broken skin
use only as directed
Otc - Stop Use
Stop use and ask a doctor if irritation occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
FIRST USE:
Twist the top of the pen several times
to prime. Wait 1-2 minutes for the
solution to reach the brush tip.
DAILY USE:
File the affected nail surface gently.
Twist the top of the pen a few times
to release the solution.
Apply evenly to the nail surface and
edges. Allow to dry completely.
Use twice daily for best results.
Other Information
Store at room temperature. Keep cap tightly closed.
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Canola Oil,Eugenia
Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia
(Lavender) Oil, Simmondsia Chinensis (Jojoba) Seed Oil,
Leptospermum Scoparium Branch/LeafOil,Origanum
Vulgare Oil, Mentha Piperita (Peppermint) Oil, Propolis
Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil,
Melaleuca Alternifolia(Tea Tree) Leaf Oil, Tocopherol
Package Label - Principal Display Panel
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